Advocacy - Lab Advocate
ADLM continues to oppose the Food & Drug Administration’s newly asserted authority to regulate laboratory-developed tests (LDTs). Historically, LDTs, which are vital for diagnosing rare conditions and providing critical data when no other tests suffice, have been governed by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). Approximately 12,000 laboratories in the United States currently perform these essential tests.
FDA published a final rule on May 6, 2024, expanding its regulatory reach to include LDTs, classifying laboratories that perform these tests as medical device manufacturers. This rule has sparked considerable concern within the healthcare community, particularly among those in academic medical centers and other laboratories whose patients depend on their ability to develop, verify, and perform these critical tests. The association has consistently argued that such regulation introduces unnecessary and costly layers of oversight, duplicating existing CLIA requirements and potentially forcing laboratories to cease offering LDTs.
In response to the FDA's unilateral action, the American Clinical Laboratory Association (ACLA) filed a lawsuit on May 29, 2024, in the U.S. District Court for the Eastern District of Texas. The lawsuit challenges the FDA's authority, claiming that the final rule exceeds the agency’s statutory powers and constitutes regulatory overreach.
To help laboratories navigate the new regulatory landscape, ADLM hosted a webinar on June 3rd featuring experts such as Dr. Stephen R. Master, MD, PhD, from the Children's Hospital of Philadelphia, and Dr. Jonathan Genzen, MD, PhD, from the University of Utah. The webinar covered the scope and intent of the FDA’s new rule, the regulatory requirements, exceptions, and the implementation timeline. Participants learned about the strategic decisions laboratories need to make and the resources required to comply with the new regulations. We invite you to watch the recorded webinar to gain a deeper understanding of this regulation and its impact on your laboratory operations.
The FDA itself hosted a webinar on May 14, 2024, to provide an overview of the Final Rule: Medical Devices; Laboratory Developed Tests. This session detailed the final rule’s impact, including the phaseout of the FDA's general enforcement discretion approach to LDTs. You can watch the recording of this FDA webinar here.
ADLM remains committed to advocating for balanced regulation that safeguards patient care and fosters innovation in laboratory-developed tests. The association will continue collaborating with policymakers and allied stakeholders to create a supportive regulatory environment.